慢性特発性蕁麻疹市場 - 市場の洞察、疫学、市場予測：2034年

主なハイライト

• 主要7ヶ国の慢性特発性蕁麻疹市場規模は2023年に約21億7,330万米ドルとなっています。2024年から2034年までの予測期間において、この市場は、レミブルチニブ（LOU064）、TEZSPIRE（テゼペルマブ）、リルザブルチニブ（SAR444671）などの革新的な治療法の導入や、認知度の向上、診断能力の向上により、CAGR10%以上で成長すると予測されます。さらに、抗生物質の使用増加などの要因によって影響を受ける可能性のある免疫系機能の変化もあります。
• 2023年、主要7ヶ国における慢性特発性蕁麻疹の診断有病者数は約280万人でした。このうち米国は19％近くを占め、EU4ヶ国と英国は44％、日本は38％を占めています。
• 欧州委員会が最近承認したOMLYCLO（CT-P39）と日本の厚生労働省が承認したDUPIXENT（デュピルマブ）は、治療情勢に大きな変化をもたらし、市場競争を激化させ、採用や価格戦略に影響を与える可能性のある費用対効果の高い代替品を導入するものです。
• XOLAIR（オマリズマブ）やDUPIXENT（デュピルマブ）のような治療法は利用可能であるが、多くの患者は依然として再発や不十分な症状コントロールに直面しています。高用量のH1-抗ヒスタミン薬には鎮静作用や抗コリン作用などの重篤な副作用があり、XOLAIRにはアナフィラキシーのリスクがあります。このことは、より安全で効果的な代替薬の必要性を浮き彫りにしています。
• バイオシミラーの台頭、疾患像の多様化、患者履歴の不完全さ、ジェネリック医薬品やOTC製品の使用拡大などは、既存治療薬と新規治療薬の双方に大きな課題をもたらし、その有効性と市場導入の妨げとなる可能性があります。

当レポートは、慢性特発性蕁麻疹の詳細、過去の疫学と予測、米国、EU4ヶ国（ドイツ、フランス、イタリア、スペイン）、英国、日本の慢性特発性蕁麻疹市場動向をお届けします。

当レポートは、現在の治療法、新薬、個々の治療法の市場シェア、2020年から2034年までの主要7ヶ国慢性特発性蕁麻疹市場規模の現状と予測を提供します。また、慢性特発性蕁麻疹治療市場の実践/アルゴリズムやアンメットメディカルニーズも網羅し、最良の機会を発掘し、市場の可能性を評価します。

蕁麻疹は、血管浮腫を伴う、または伴わない、一般的で不均一な炎症性皮膚疾患です。皮膚肥満細胞の活性化と脱顆粒、それに続くヒスタミンやその他のメディエーターの放出により、感覚神経の活性化、血管拡張、血漿の滲出、細胞の動員を引き起こし、膨疹、血管浮腫、またはその両方を呈します。蕁麻疹は、エピソードの発現が6週間未満または6週間以上持続するかによって、それぞれ急性または慢性に分類されます。

慢性蕁麻疹は自然発症または誘発性で、6週間以上持続し、1年以上持続します。慢性の蕁麻疹はQOLに影響を与え、精神疾患の併存や高額なヘルスケアコストと関連し、しばしば患者に大きな社会経済的苦痛を与えます。原因不明の慢性自然蕁麻疹とは対照的に、慢性誘発性蕁麻疹は、徴候や症状を誘発する明確で亜型特異的な誘因があります。

診断は身体診察および病歴に基づいて行われます。基礎疾患を除外するため、あるいは誘発因子を同定するために、血液検査、アレルギー検査、皮膚生検などの追加検査が行われます。甲状腺機能、抗甲状腺ペルオキシダーゼ抗体および抗サイログロブリン抗体のスクリーニング検査が推奨されます。自己血清皮膚検査（ASST）が陽性であること、および好塩基球ヒスタミン遊離測定法（BHRA）による抗FCeRIa抗体または抗IgE自己抗体の患者血清のin vitro検査も推奨されます。

疾患活動性（例：蕁麻疹活動性スコア）、疾患コントロール（例：蕁麻疹コントロールテスト）、QOLへの影響（例：慢性蕁麻疹QOL指標）を評価するためのツールも開発されています。治療方針の決定や経過の観察に役立てるため、ベースライン評価を行うべきです。

慢性特発性蕁麻疹の治療は課題であり、治療目標は疾患活動性の低下、症状の完全コントロール、QoLの改善です。現在の治療方針は症状を緩和し、再発を予防することを目的としています。治療パターンとしては、第一選択治療から始め、より高度な選択肢へと段階的に進めていくのが一般的です。

ガイドラインでは、第一選択薬として第二世代のH1-抗ヒスタミン薬（セチリジン、ロラタジン、フェキソフェナジン）の使用を推奨しています。抗コリン作用と中枢神経系への副作用プロファイルのため、第一世代H1-抗ヒスタミン薬のルーチン使用はもはや推奨されていないが、臨床現場ではまだ使用されています。標準用量に反応しない慢性特発性蕁麻疹の患者には、治療の次の段階として第2世代のH1-抗ヒスタミン薬を4倍まで増量することが推奨されます。H2抗ヒスタミン薬はしばしばH1抗ヒスタミン薬と併用され、慢性特発性蕁麻疹の症状コントロールを改善します。

• 2023年の主要7ヶ国における慢性特発性蕁麻疹診断有病者総数は約280万人であり、予測期間中（2024～2034年）に変化すると予測されます。
• 米国では、2023年の慢性特発性蕁麻疹診断有病者数は約52.1万人で、主要7ヶ国全体の約19%でした。
• EU4ヶ国と英国の中で、2023年に診断された慢性の自然発症の蕁麻疹有病者数が最も多かったのはドイツで約32万7,000症例、次いでフランスが約25万5,000症例でした。一方、最も少なかったのはスペインで約16万3,000症例でした。
• 2023年の慢性特発性蕁麻疹診断有病者数は日本が最も多く、約100万人でした。
• 米国における慢性特発性蕁麻疹の年齢別診断有病者数のうち、2023年には、 18歳未満, 18～29歳, 30～39歳, 40～49歳, 50～59歳, and>=60歳以上、それぞれ約4万7,000人、約8万人、約7万2,000人、約8万1,000人、約8万6,000人、約15万6,000人でした。
• 2023年のEU4ヶ国および英国における慢性特発性蕁麻疹の患者数は、男性約39万1,000人、女性約83万9,000人でした。
• 日本では、2023年の慢性特発性蕁麻疹の軽症例は約46千例、中等症例は約69万例、重症例は約32万6,000例でした。

ゾレア（オマリズマブ）は、ヒトIgEに選択的に結合する組換えDNA由来のヒト化IgG1κモノクローナル抗体です。オマリズマブは、抗生物質ゲンタマイシンを含む可能性のある栄養培地でのチャイニーズハムスター卵巣（CHO）細胞懸濁培養により産生されますが、最終製品ではゲンタマイシンは検出されません。オマリズマブはIgEと結合し、遊離IgEレベルを低下させる。その後、細胞上のIgE受容体（FcεRI）の発現が低下します。また、オマリズマブのこうした作用がCIU症状の改善につながるメカニズムは不明です。2018年12月、欧州委員会（EC）はXOLAIR（オマリズマブ）の自己投与用プレフィルドシリンジ（PFS）を承認し、慢性特発性蕁麻疹の患者が治療薬を投与できるようになっています。

2018年9月、米国FDAは慢性自然蕁麻疹の追加製剤として、XOLAIRの75mg/0.5mLおよび150mg/1mLの単回投与用プレフィルドシリンジを承認しました。2017年3月、PMDAは、慢性自然蕁麻疹の治療薬として、新たな効能・効果および用法・用量（SC注射液150mgおよび75mg）を追加したゾラエアを承認しました。2014年3月、米国FDAおよびECは、H1-抗ヒスタミン薬治療にもかかわらず症状の残る12歳以上の患者を対象とした慢性特発性蕁麻疹の治療薬として、XOLAIR（オマリズマブ）を承認しました。

2024年5月、ECはXOLAIRを参照するオマリズマブのバイオシミラーであるOMLYCLO（CT-P39）を承認しました。

慢性特発性蕁麻疹新興治療薬

• レミブルチニブ（LOU064）：Novartis Pharmaceuticals

レミブルチニブ（LOU064）は、B細胞やミクログリアなど特定の免疫細胞の炎症活性に重要な役割を果たすブルトン型チロシンキナーゼ（BTK）酵素を強力かつ選択的に阻害する経口治療薬です。レミブルチニブは、肥満細胞や好塩基球のIgE架橋によって誘発される脱顆粒や、自然発症および誘発性の慢性蕁麻疹患者の血清中に存在する因子によって誘発される活性化を阻害します。

レミブルチニブは現在、H1-抗ヒスタミン薬によるコントロールが不十分な慢性特発性蕁麻疹を対象とした第III相臨床試験が行われています。この薬剤は、再発性多発性硬化症やピーナッツアレルギーなどの他の適応症でも開発中です。

最近ノバルティスは、慢性特発性蕁麻疹におけるレミブルチニブの長期有効性と安全性を確認する新たなデータを発表しました。主要な第III相試験であるREMIX-1およびREMIX-2において、レミブルチニブ治療は、第2世代のH1-抗ヒスタミン薬を使用しても症状が持続する慢性特発性蕁麻疹の患者において、早期に有意な症状の改善を示しました。さらに、同社はレミブルチニブを2025年に承認申請する予定です。データは欧州アレルギー臨床免疫学会（EAACI）2024で発表されました。

• TEZSPIRE（テゼペルマブ）：AstraZeneca/Amgen

TEZSPIRE（テゼペルマブ[AMG 157]）は、複数の炎症カスケードの最上位に位置し、アレルギー性疾患、好酸球性疾患、気道炎症疾患の発症と持続に重要な鍵となる上皮性サイトカインである胸腺間質リンパポエチン（TSLP）の作用を阻害するファースト・イン・クラスのヒトモノクローナル抗体として、アストラゼネカがアムジェンと共同開発しています。TSLP、IL-25、IL-33は、上皮上の異なるトリガーに続いて放出され、Th2炎症反応を開始し、Th2細胞におけるT細胞の分極化を媒介します。TSLP阻害作用を有するテゼペルマブは、慢性特発性蕁麻疹患者の皮膚病変を予防・治療すると思われます。

この薬剤は、慢性特発性蕁麻疹の治療薬として、第II相試験（INCEPTION試験）を終了し、結果を公表していますが、その後の更新はありません。さらに、TEZSPIREは米国、EU、日本、およびその他の国々で重症喘息の治療薬として承認されています。また、米国では12歳以上の成人および小児の重症喘息患者に対する追加維持療法として承認されています。さらに、COPD、鼻ポリープを伴う慢性鼻副鼻腔炎、好酸球性食道炎など、他の適応症の可能性も検討されています。

慢性特発性蕁麻疹は、皮膚にじんましんや膨疹が繰り返し現れることを特徴とする慢性疾患です。慢性特発性蕁麻疹は、6週間以上症状が持続する皮膚のアレルギー性疾患です。診断は身体診察と病歴に基づいて行われます。基礎疾患を除外するため、あるいは誘因を特定するために、血液検査、アレルギー検査、皮膚生検などの追加検査が行われます。慢性特発性蕁麻疹の治療は困難であり、治療目標は疾患活動性の低下、症状の完全コントロール、QoLの改善です。現在の治療方針は症状を緩和し、再発を予防することを目的としています。治療パターンは一般的に段階的アプローチを含み、第一選択治療から開始し、必要に応じてより高度な選択肢へと進みます。

治療は一般的に、昼間は非鎮静性抗ヒスタミン薬、夜間は鎮静性抗ヒスタミン薬で開始されます。H2抗ヒスタミン薬は、慢性特発性蕁麻疹においてより良好な症状コントロールを達成するためにH1抗ヒスタミン薬と併用されることが多く、消化不良や酸味を訴える場合には追加されます。慢性特発性蕁麻疹に最もよく使用されるH2抗ヒスタミン薬はラニチジンです。しかし、ラニチジンは安全性の懸念から多くの市場から撤退していることに注意することが重要です。

しかし、多くの患者では症状のコントロールが得られず、標準用量のH1-抗ヒスタミン薬が奏効する患者は半数以下です。傾眠などの副作用は影響を受けやすい人に起こる可能性があり、投与量を増やしたにもかかわらず治療負担が増加します。

NovartisとGenentechのXOLAIRは、H1-抗ヒスタミン薬治療にもかかわらず症状の残る12歳以上の慢性自然蕁麻疹患者に対して承認された生物学的製剤です。慢性特発性蕁麻疹において、オマリズマブは膨疹および血管浮腫の開発を予防し、QOLを改善し、長期治療に適し、治療中止後の再発を効果的に治療します。オマリズマブは、H1-抗ヒスタミン薬治療にもかかわらず症状の残る慢性特発性蕁麻疹の治療薬として米国、欧州、日本で承認されています。

しかし、オマリズマブを投与しても症状が改善しない患者が3分の1近くおり、SC投与はヘルスケア・インフラと患者にさらなる負担を強います。

現在の慢性特発性蕁麻疹治療薬市場は、全体的な処方パターンにわずかな差異を示す主要7ヶ国全体の一般的な治療パターンに基づいて、一般的に使用されるさまざまな治療クラスにセグメント化されています。経口コルチコステロイド、処方抗ヒスタミン薬、ロイコトリエン受容体拮抗薬、免疫抑制剤、XOLAIR、その他が予測モデルでカバーする主な薬剤です。

• Novartis Pharmaceuticalsのremibrutinib（LOU064）、AstraZeneca/AmgenのTEZSPIRE（tezepelumab）、SanofiのRilzabrutinib（SAR444671）などの主要な慢性特発性蕁麻疹開発企業は、臨床開発のさまざまな段階で主な候補薬を評価しています。これらの企業は、慢性特発性蕁麻疹の治療薬として自社製品を検討することを目指しています。
• 主要7ヶ国の慢性特発性蕁麻疹治療市場規模合計は、2023年に約21億7,330万米ドルであり、予測期間中（2024～2034年）に増加すると予測されます。
• 米国における慢性特発性蕁麻疹治療市場規模は、2023年に約11億9,470万米ドルであり、疾患に対する認知度の向上と新興治療薬の発売により、調査期間中にCAGR 9.5%で増加すると予測されます。
• EU4ヶ国と英国における慢性特発性蕁麻疹治療市場規模は、2023年に約6億米ドルと算出され、これは主要7ヶ国の総市場収益の約28%に相当します。
• EU4ヶ国と英国の中で、2023年の慢性特発性蕁麻疹治療市場規模が最も大きかったのはドイツで約1億5,930万米ドル、次いでフランスが約1億3,950万米ドル、最も小さかったのはスペインで約7,810万米ドルでした。
• 米国では、NovartisのXOLAIRが2023年に約9億1,300万米ドルの売上高で全療法の中で最も高い市場シェアを占め、処方抗ヒスタミン薬が1億3,800万米ドル、免疫抑制剤が1億2,300万米ドルでこれに続きました。
• 2023年、日本の慢性特発性蕁麻疹治療市場規模は、主要7ヶ国の市場規模全体の約18.2%を占め、売上高は約3億7,860万米ドルでした。

当レポートでは、主要7ヶ国における慢性特発性蕁麻疹市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2034年までの市場規模予測、および医療のアンメットニーズなどを提供しています。

目次

第1章 重要な洞察

第2章 報告書のイントロダクション

第3章 慢性特発性蕁麻疹市場概要

• 2020年の慢性特発性蕁麻疹の市場シェア（％）分布
• 2034年の慢性特発性蕁麻疹の市場シェア（％）分布

第4章 慢性特発性蕁麻疹の疫学と市場の調査手法

第5章 慢性特発性蕁麻疹のエグゼクティブサマリー

第6章 主要な出来事

第7章 疾患の背景と概要

• イントロダクション
• 兆候と症状
• 分類
  • 蕁麻疹の持続期間と誘発因子の関連性に基づく分類
• 原因
• 病因
• 病態生理学
  • 肥満細胞の役割
  • 血清因子
  • 凝固カスケード
  • 好塩基球
  • 好酸球
  • リンパ球
  • 自己免疫理論
• 臨床症状
• 診断
• 治療と管理
• 慢性特発性蕁麻疹の治療
• 慢性特発性蕁麻疹の管理

第8章 患者動向

第9章 疫学と患者人口

• 主な調査結果
• 前提と根拠：主要7ヶ国
  • 慢性蕁麻疹の有病例
  • 慢性蕁麻疹の種類別症例
  • 年齢別にみた慢性特発性蕁麻疹の症例
  • 慢性特発性蕁麻疹の症例、性別
  • 慢性特発性蕁麻疹の重症度別症例
• 主要7ヶ国における慢性特発性蕁麻疹の診断された有病症例の総数
• 米国
  • 米国における慢性蕁麻疹の総診断症例数
  • 米国における慢性特発性蕁麻疹の症例、種類別
  • 米国における慢性特発性蕁麻疹の症例、性別
  • 米国における慢性特発性蕁麻疹の症例、年齢別
  • 米国における慢性特発性蕁麻疹の症例、重症度別
• EU4ヶ国と英国
  • EU4ヶ国と英国における慢性蕁麻疹の総診断症例数
  • EU4ヶ国と英国における慢性特発性蕁麻疹の症例、種類別
  • EU4ヶ国と英国における慢性特発性蕁麻疹の症例、性別
  • EU4ヶ国と英国における慢性特発性蕁麻疹の症例、年齢別
  • EU4ヶ国と英国における慢性特発性蕁麻疹の症例、重症度別
• 日本
  • 日本における慢性蕁麻疹の総診断症例数
  • 日本における慢性特発性蕁麻疹の症例、種類別
  • 日本における慢性特発性蕁麻疹の症例、性別
  • 日本における慢性特発性蕁麻疹の症例、年齢別
  • 日本における慢性特発性蕁麻疹の症例、重症度別

第10章 市販薬

• XOLAIR（オマリズマブ）：Roche/Novartis

第11章 新興医薬品

• キークロス競合
• レミブルチニブ（LOU064）：Novartis Pharmaceuticals
• デュピクセント（デュピルマブ）：Sanofi/Regeneron
• ファセンラ（ベンラリズマブ）：AstraZeneca/Kyowa Hakko Kirin
• リレンテリマブ（AK002）：Allakos/BioWa
• TEZSPIRE（テゼペルマブ）：AstraZeneca/Amgen
• リルザブルチニブ（SAR444671）：Sanofi
• TAS5315：Taiho Pharmaceutical
• バルゾルボリマブ（CDX-0159）：Celldex Therapeutics

第12章 慢性特発性蕁麻疹：市場分析

第13章 主要オピニオンリーダーの見解

第14章 SWOT

第15章 アンメットニーズ

第16章 市場アクセスと償還

• 米国
  • メディケア・メディケイドサービスセンター（CMS）
• EU4ヶ国と英国
  • ドイツ
  • フランス
  • イタリア
  • スペイン
  • 英国
• 日本
  • 厚生労働省

第17章 付録

第18章 DelveInsightのサービス内容

第19章 免責事項

List of Tables

• Table 1: Summary of Market and Epidemiology (2020-2034)
• Table 2: British Society for Allergy and Clinical Immunology (BSACI) Guidelines
• Table 3: Symptomatic pharmacological treatment Guidelines
• Table 4: Total Diagnosed Prevalent Cases of Chronic Spontaneous Urticaria in the 7MM (2020-2034)
• Table 5: Total Diagnosed Prevalent Cases of Chronic Urticaria in the US (2020-2034)
• Table 6: Type-specific Cases of Chronic Urticaria in the US (2020-2034)
• Table 7: Gender-specific Cases of Chronic Spontaneous Urticaria in the US (2020-2034)
• Table 8: Age-specific Cases of Chronic Spontaneous Urticaria in the US (2020-2034)
• Table 9: Severity-specific Cases of Chronic Spontaneous Urticaria in the US (2020-2034)
• Table 10: Total Diagnosed Prevalent Cases of Chronic Urticaria in EU4 and the UK (2020-2034)
• Table 11: Type-specific Cases of Chronic Urticaria in EU4 and the UK (2020-2034)
• Table 12: Gender-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK (2020-2034)
• Table 13: Age-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK (2020-2034)
• Table 14: Severity-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK (2020-2034)
• Table 15: Total Diagnosed Prevalent Cases of Chronic Urticaria in Japan (2020-2034)
• Table 16: Type-specific Cases of Chronic Urticaria in Japan (2020-2034)
• Table 17: Gender-specific Cases of Chronic Spontaneous Urticaria in Japan (2020-2034)
• Table 18: Age-specific Cases of Chronic Spontaneous Urticaria in Japan (2020-2034)
• Table 19: Severity-specific Cases of Chronic Spontaneous Urticaria in Japan (2020-2034)
• Table 20: XOLAIR (omalizumab), Clinical Trial Description, 2023
• Table 21: Remibrutinib (LOU064), Clinical Trial Description, 2023
• Table 22: DUPIXENT (dupilumab), Clinical Trial Description, 2023
• Table 23: FASENRA (benralizumab), Clinical Trial Description, 2023
• Table 24: Lirentelimab (AK002), Clinical Trial Description, 2023
• Table 25: TEZSPIRE (tezepelumab), Clinical Trial Description, 2023
• Table 26: Rilzabrutinib (SAR444671), Clinical Trial Description, 2023
• Table 27: TAS5315, Clinical Trial Description, 2023
• Table 28: Barzolvolimab (CDX-0159), Clinical Trial Description, 2023
• Table 29: Key Market Forecast Assumptions for Remibrutinib (LOU064)
• Table 30: Key Market Forecast Assumptions for DUPIXENT (dupilumab)
• Table 31: Key Market Forecast Assumptions for FASENRA (benralizumab)
• Table 32: Key Market Forecast Assumptions for Lirentelimab (AK002)
• Table 33: Key Market Forecast Assumptions for TEZSPIRE (tezepelumab)
• Table 34: Total Market Size of Chronic Spontaneous Urticaria in the 7MM, in USD million (2020-2034)
• Table 35: Total Market Size of Chronic Spontaneous Urticaria by Therapies in the 7MM, in USD million (2020-2034)
• Table 36: Market Size of Chronic Spontaneous Urticaria in the US, in USD million (2020-2034)
• Table 37: Market Size of Chronic Spontaneous Urticaria by Therapies in the US, in USD million (2020-2034)
• Table 38: Market Size of Chronic Spontaneous Urticaria in EU4 and the UK, in USD million (2020-2034)
• Table 39: Market Size of Chronic Spontaneous Urticaria by Therapies in EU4 and the UK, in USD million (2020-2034)
• Table 40: Market Size of Chronic Spontaneous Urticaria in Japan, in USD million (2020-2034)
• Table 41: Market Size of Chronic Spontaneous Urticaria by Therapies in Japan, in USD million (2020-2034)

List of Figures

• Figure 1: Classification
• Figure 2: Pathophysiology of Chronic Spontaneous Urticaria
• Figure 3: Model of the Mechanisms Underlying Chronic Urticaria
• Figure 4: Treatment Algorithm
• Figure 5: Step-care Approach to the Treatment for Chronic Urticaria
• Figure 6: Guidelines Supported by the Centre of Evidence of the French Society of Dermatology
• Figure 7: Comparison of Treatment Algorithm
• Figure 8: Treatment Algorithm
• Figure 9: Patient Journey
• Figure 10: Total Diagnosed Prevalent Cases of Chronic Spontaneous Urticaria in the 7MM (2020-2034)
• Figure 11: Total Diagnosed Prevalent Cases of Chronic Urticaria in the US (2020-2034)
• Figure 12: Type-specific Cases of Chronic Urticaria in the US (2020-2034)
• Figure 13: Gender-specific Cases of Chronic Spontaneous Urticaria in the US (2020-2034)
• Figure 14: Age-specific Cases of Chronic Spontaneous Urticaria in the US (2020-2034)
• Figure 15: Severity-specific Cases of Chronic Spontaneous Urticaria in the US (2020-2034)
• Figure 16: Total Diagnosed Prevalent Cases of Chronic Urticaria in EU4 and the UK (2020-2034)
• Figure 17: Type-specific Cases of Chronic Urticaria in EU4 and the UK (2020-2034)
• Figure 18: Gender-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK (2020-2034)
• Figure 19: Age-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK (2020-2034)
• Figure 20: Severity-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK (2020-2034)
• Figure 21: Total Diagnosed Prevalent Cases of Chronic Urticaria in Japan (2020-2034)
• Figure 22: Type-specific Cases of Chronic Urticaria in Japan (2020-2034)
• Figure 23: Gender-specific Cases of Chronic Spontaneous Urticaria in Japan (2020-2034)
• Figure 24: Age-specific Cases of Chronic Spontaneous Urticaria in Japan (2020-2034)
• Figure 25: Severity-specific Cases of Chronic Spontaneous Urticaria in Japan (2020-2034)
• Figure 26: Total Market Size of Chronic Spontaneous Urticaria in the 7MM, in USD million (2020-2034)
• Figure 27: Total Market Size of Chronic Spontaneous Urticaria by Therapies in the 7MM, in USD million (2020-2034)
• Figure 28: Market Size of Chronic Spontaneous Urticaria in the US, in USD million (2020-2034)
• Figure 29: Market Size of Chronic Spontaneous Urticaria by Therapies in the US, in USD million (2020-2034)
• Figure 30: Market Size of Chronic Spontaneous Urticaria in EU4 and the UK, in USD million (2020-2034)
• Figure 31: Market Size of Chronic Spontaneous Urticaria by Therapies in EU4 and the UK, in USD million (2020-2034)
• Figure 32: Market Size of Chronic Spontaneous Urticaria in Japan, in USD million (2020-2034)
• Figure 33: Market Size of Chronic Spontaneous Urticaria by Therapies in Japan, in USD million (2020-2034)
• Figure 34: SWOT Analysis of Chronic Spontaneous Urticaria
• Figure 35: Unmet Needs
• Figure 36: Health Technology Assessment
• Figure 37: Reimbursement Process in Germany
• Figure 38: Reimbursement Process in France
• Figure 39: Reimbursement Process in Italy
• Figure 40: Reimbursement Process in Spain
• Figure 41: Reimbursement Process in the United Kingdom
• Figure 42: Reimbursement Process in Japan

Key Highlights:

• According to DelveInsight's analysis, the Chronic Spontaneous Urticaria Market Size in the 7MM was valued at approximately USD 2,173.3 million in 2023. Over the forecast period from 2024 to 2034, this market is projected to grow at a CAGR of more than 10%, driven by the introduction of innovative therapies such as remibrutinib (LOU064), TEZSPIRE (Tezepelumab), and Rilzabrutinib (SAR444671), as well as increased awareness and better diagnostic capabilities. Additionally, changes in immune system function, potentially influenced by factors such as the increased use of antibiotics.
• According to DelveInsight's estimates, in 2023, there were approximately 2.8 million Chronic Spontaneous Urticaria Diagnosed Prevalent Cases in the 7MM. Of these, the US accounted for nearly 19% of the cases, while the EU4 and the UK accounted for 44% and Japan represented 38% of the cases, respectively.
• The recent approvals of OMLYCLO (CT-P39) by the European Commission and DUPIXENT (Dupilumab) by Japan's MHLW mark a major shift in the treatment landscape, introducing cost-effective alternatives that could increase market competition and influence adoption and pricing strategies.
• Although treatments like XOLAIR (omalizumab) and DUPIXENT (dupilumab) are available, many patients still face relapses or insufficient symptom control. Higher doses of H1-antihistamines come with serious side effects, such as sedation and anticholinergic effects, and XOLAIR has a risk of anaphylaxis. This highlights the need for safer and more effective alternatives.
• The rise of biosimilars, variable disease presentations, and incomplete patient histories, along with the growing use of generics and OTC products, might pose significant challenges to both existing and new therapies, potentially hindering their effectiveness and market adoption.

DelveInsight's "Chronic Spontaneous Urticaria Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of Chronic Spontaneous Urticaria, historical and forecasted epidemiology, as well as the Chronic Spontaneous Urticaria market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Chronic Spontaneous Urticaria Treatment Market Report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM chronic spontaneous urticaria market size from 2020 to 2034. The report also covers Chronic Spontaneous Urticaria Treatment Market practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Chronic Spontaneous Urticaria Treatment Market: Understanding and Algorithm

Urticaria is a common and heterogeneous inflammatory skin disorder with or without associated angioedema. It presents with wheals, angioedema, or both due to activation and degranulation of skin mast cells, followed by the release of histamine and other mediators leading to sensory nerve activation, vasodilatation, plasma extravasation, and cellular recruitment. It is classified as acute or chronic, depending on whether the onset of episodes lasts for less or >6 weeks, respectively.

Chronic urticaria is spontaneous or inducible, lasts >6 weeks, and persists for >1 year. It impacts the quality of life and is linked to psychiatric comorbidities and high healthcare costs, often causing huge socio-economic distress for the patients. In contrast to chronic spontaneous urticaria, where the cause is unknown, chronic inducible urticaria has definite and subtype-specific triggers that induce signs and symptoms.

Chronic Spontaneous Urticaria Diagnosis

The diagnosis is based on a physical examination and medical history. Additional tests are performed to rule out underlying causes or to identify triggers, such as blood tests, allergy tests, or skin biopsies. Screening tests for thyroid function and antithyroid peroxidase and antithyroglobulin antibodies are recommended. Positive autologous serum skin test (ASST) and in vitro testing of the patient's serum for the anti-FCeRIa or the anti-IgE autoantibodies by basophil histamine release assay (BHRA) is also recommended.

Some tools have been developed to assess disease activity (e.g., urticaria activity score), disease control (e.g., urticaria control test), and impacts on quality of life (e.g., chronic urticaria quality of life index). Baseline assessments should be performed to help guide treatment decisions and monitor progress.

Chronic Spontaneous Urticaria Treatment

Treating chronic spontaneous urticaria is challenging, and the therapeutic goal is a reduction in disease activity, complete symptom control, and improvement in QoL. The current treatment regime aims to alleviate symptoms and prevent their recurrence. The treatment pattern typically involves a stepwise approach, starting with first-line treatments and progressing to more advanced options.

The guidelines recommend using second-generation H1-antihistamines (cetirizine, loratadine, fexofenadine) as the first-line pharmacological treatment. Due to anticholinergic properties and the adverse effect profile on the central nervous system, the routine use of first-generation H1-antihistamines is no longer recommended, though they are still used in clinical practice. The up-dosing of second-generation H1-antihistamine up to fourfold in patients with chronic spontaneous urticaria unresponsive to a standard dose is further recommended as the next step in treatment. H2 antihistamines are often combined with H1 to achieve better symptom control in chronic spontaneous urticaria.

Chronic Spontaneous Urticaria Epidemiology

As the market is derived using a patient-based model, the Chronic Spontaneous Urticaria epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented total diagnosed prevalent cases of chronic urticaria, type-specific cases of chronic urticaria, total diagnosed prevalent cases of chronic spontaneous urticaria, age-specific cases of chronic spontaneous urticaria, gender-specific cases of chronic spontaneous urticaria, and severity-specific cases of chronic spontaneous urticaria in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• According to DelveInsight's epidemiology model, the total Chronic Spontaneous Urticaria Diagnosed Prevalent Cases were approximately 2.8 million among the 7MM in 2023 which is expected to change during the forecast period (2024-2034).
• In the US, there were approximately 521 thousand Chronic Spontaneous Urticaria Diagnosed Prevalent Cases in 2023 which was nearly 19% of the total 7MM.
• Among the EU4 and the UK, Germany had the highest Chronic Spontaneous Urticaria Diagnosed Prevalent Cases in 2023 with approximately 327 thousand cases followed by France with nearly 255 thousand cases. On the other hand, Spain accounted for the least with approximately 163 thousand cases.
• In 2023, Japan accounted for the highest Chronic Spontaneous Urticaria Diagnosed Prevalent Cases with approximately 1 million cases.
• Among the age-specific diagnosed prevalent cases of chronic spontaneous urticaria in the US, there were approximately 47 thousand, 80 thousand, 72 thousand, 81 thousand, 86 thousand, and 156 thousand cases in the age groups <18, 18-29, 30-39, 40-49, 50-59, and >=60, respectively, in 2023.
• There were approximately 391 thousand male and 839 thousand female cases of chronic spontaneous urticarial among EU4 and the UK in 2023.
• In Japan, there were approximately 46 thousand mild cases, 690 thousand moderate cases, and 326 thousand severe cases of chronic spontaneous urticaria in 2023.

Chronic Spontaneous Urticaria Drug Chapters

The drug chapter segment of the Chronic Spontaneous Urticaria therapeutics market report encloses a detailed analysis of Chronic Spontaneous Urticaria-marketed drugs and mid to late-stage (Phase III and Phase II) Chronic Spontaneous Urticaria pipeline drugs analysis. It also helps understand the Chronic Spontaneous Urticaria clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest Chronic Spontaneous Urticaria news and press releases.

Chronic Spontaneous Urticaria Marketed Drugs

• XOLAIR (omalizumab): Roche/Novartis

XOLAIR (omalizumab) is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human IgE. It is produced by a Chinese hamster ovary (CHO) cell suspension culture in a nutrient medium that may contain the antibiotic gentamicin; gentamicin is not detectable in the final product. Omalizumab binds to IgE and lowers free IgE levels. Subsequently, IgE receptors (FcεRI) on cells down-regulate. Also, the mechanism by which these effects of omalizumab result in an improvement of CIU symptoms is unknown. In December 2018, the European Commission (EC) approved XOLAIR (omalizumab) prefilled syringe (PFS) for self-administration, allowing patients with chronic spontaneous urticaria to administer their treatment.

In September 2018, the US FDA approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes for XOLAIR as an additional formulation for chronic spontaneous urticaria. In March 2017, the PMDA approved XOLAIR with a new additional indication and a new dosage (SC injection 150 mg and 75 mg) for treating chronic spontaneous urticaria. In March 2014, the US FDA and the EC approved XOLAIR (omalizumab) for treating chronic spontaneous urticaria for patients 12 years of age and older who remain symptomatic despite H1-antihistamine therapy.

In May 2024, the EC approved OMLYCLO (CT-P39), an omalizumab biosimilar referencing XOLAIR.

Chronic Spontaneous Urticaria Emerging Drugs

• Remibrutinib (LOU064): Novartis Pharmaceuticals

Remibrutinib (LOU064) is an oral treatment that potently and selectively inhibits Bruton's tyrosine kinase (BTK) enzyme, which plays a critical role in the inflammatory activity of certain immune cells such as B cells and microglia. Remibrutinib inhibits degranulation induced by IgE cross-linking in mast cells and basophils and the activation triggered by factors present in the sera of spontaneous and inducible chronic urticaria patients.

Remibrutinib is currently being tested in Phase III clinical studies for chronic spontaneous urticaria in patients inadequately controlled by H1-antihistamines. The drug is also being developed for other indications, including relapsing multiple sclerosis and peanut allergy.

Recently, Novartis announced new data that confirm the long-term efficacy and safety of remibrutinib in chronic spontaneous urticaria. In the pivotal Phase III studies, REMIX-1 and REMIX-2, remibrutinib treatment showed significant symptom improvement early in patients with chronic spontaneous urticaria who remained symptomatic despite second-generation H1-antihistamine use. Moreover, the company plans to plans to submit remibrutinib for regulatory approval in 2025. Data presented at European Academy of Allergy and Clinical Immunology (EAACI) 2024.

• TEZSPIRE (Tezepelumab): AstraZeneca/Amgen

TEZSPIRE (tezepelumab [AMG 157]) is being developed by AstraZeneca in collaboration with Amgen as a first-in-class human monoclonal antibody that inhibits the action of blocks thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and airway inflammation diseases. TSLP, IL-25, and IL-33 are released following different triggers on epithelia and start the Th2 inflammatory response, mediating T-cell polarization in Th2 cells. Tezepelumab with its inhibitory action of TSLP appears to prevent and treat the lesional skin of patients with chronic spontaneous urticaria.

The drug has completed a Phase II (INCEPTION) trial and posted results for the treatment of chronic spontaneous urticarial with no further updates. Moreover, TEZSPIRE is approved for treating severe asthma in the US, EU, Japan, and other countries. TEZSPIRE is also approved in the US for the add-on maintenance treatment of adult and pediatric patients aged 12 and older with severe asthma. Moreover the drug candidate is being investigated for other potential indications, including COPD, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis.

Chronic Spontaneous Urticaria Drugs Market Insights

Chronic spontaneous urticaria is a chronic condition characterized by the recurrent appearance of hives or wheals on the skin. It is a disturbing allergic condition of the skin, where symptoms persist for more than 6 weeks. The diagnosis is based on a physical examination and medical history. Additional tests are performed to rule out underlying causes or to identify triggers, such as blood tests, allergy tests, or skin biopsies. Treating chronic spontaneous urticaria is challenging, and the therapeutic goal is a reduction in disease activity, complete symptom control, and improvement in QoL. The current treatment regime aims to alleviate symptoms and prevent their recurrence. The treatment pattern typically involves a stepwise approach, starting with first-line treatments and progressing to more advanced options if necessary.

Chronic Spontaneous Urticaria Market Outlook

Treatment is generally initiated with nonsedating antihistamines in the daytime and sedating antihistamines at night. H2 antihistamines are often combined with H1 to achieve better symptom control in chronic spontaneous urticaria and are added if individuals complain of indigestion or acidity. The most commonly used H2 antihistamine for chronic spontaneous urticaria is ranitidine. However, it is important to note that ranitidine has been withdrawn from many markets due to safety concerns.

Many patients, however, do not achieve symptom control, with only less than half of patients responding to H1-antihistamines at standard doses. Adverse effects such as somnolence can occur in susceptible individuals, increasing the treatment burden, despite increasing the dose.

Novartis and Genentech's XOLAIR is an approved biologic for chronic spontaneous urticaria patients age 12 years and older who remain symptomatic despite H1-antihistamine treatment. In chronic spontaneous urticaria, omalizumab prevents wheal and angioedema development, improves the quality of life, is suitable for long-term treatment, and effectively treats relapse after discontinuation. The drug is approved in the US, Europe, and Japan for treating chronic spontaneous urticaria who remain symptomatic despite H1-antihistamine treatment.

However, almost one-third of patients remain symptomatic despite omalizumab, and the SC administration route further burdens the healthcare infrastructure and patients.

The current Chronic Spontaneous Urticaria Drugs Market has been segmented into different commonly used therapeutic classes based on the prevailing treatment pattern across the 7MM, which presents minor variations in the overall prescription pattern. Oral corticosteroids, prescription antihistamines, leukotriene receptor antagonists, immunosuppressive agents, XOLAIR, and others are the major drugs covered in the forecast model.

• Key Chronic Spontaneous Urticaria Companies such as Novartis Pharmaceuticals' remibrutinib (LOU064), AstraZeneca/Amgen's TEZSPIRE (tezepelumab), and Sanofi's Rilzabrutinib (SAR444671), among others, are evaluating their lead candidates in different stages of clinical development. They aim to investigate their products to treat chronic spontaneous urticaria.
• The total Chronic Spontaneous Urticaria Treatment Market Size in the 7MM was approximately USD 2,173.3 million in 2023 and is projected to increase during the forecast period (2024-2034).
• The Chronic Spontaneous Urticaria Treatment Market Size in the US was approximately USD 1,194.7 million in 2023 and will increase at a CAGR of 9.5% during the study period driven by the increasing awareness of the disease and the launch of the emerging therapy.
• The total Chronic Spontaneous Urticaria Treatment Market Size in EU4 and the UK was calculated to be approximately USD 600 million in 2023, which was nearly 28% of the total market revenue for the 7MM.
• Among EU4 and the UK, Germany accounted for the highest Chronic Spontaneous Urticaria Treatment Market Size with approximately USD 159.3 million in 2023, followed by France with approximately USD 139.5 million in the respective year, while Spain accounted for the lowest market with nearly USD 78.1 million in 2023.
• In the US, Novartis' XOLAIR had the highest market share among all the therapies, in 2023, with a revenue of approximately USD 913 million, followed by prescription antihistamines and immunosuppressive agents, with USD 138 million and USD 123 million respectively.
• In 2023, the Chronic Spontaneous Urticaria Treatment Market Size in Japan was nearly 18.2% of the total market size in the 7MM, with a revenue of approximately USD 378.6 million.

Chronic Spontaneous Urticaria Drugs Uptake

This section focuses on the uptake rate of potential Chronic Spontaneous Urticaria drugs expected to be launched in the market during 2020-2034. For example, Novartis Pharmaceuticals' remibrutinib (LOU064), a BTK inhibitor, is expected to enter the US market by 2025 and is projected to have a slow uptake during the forecast period.

Chronic Spontaneous Urticaria Pipeline Development Activities

The Chronic Spontaneous Urticaria therapeutics market report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key Chronic Spontaneous Urticaria Companies involved in developing targeted therapeutics.

Pipeline Development Activities

The Chronic Spontaneous Urticaria therapeutics market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for Chronic Spontaneous Urticaria.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on chronic spontaneous urticaria evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the University of Texas Health Science Center, Johns Hopkins University, Harvard Medical School, King's College in London, Fondation Fondamental in Creteil, and the University of Shizuoka were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or chronic spontaneous urticaria market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Physician's view

According to our primary research analysis, though the current treatment guideline recommends the use of second-generation H1-antihistamines (cetirizine, loratadine, fexofenadine) as the first-line pharmacological treatment, followed by up-dosing in patients with chronic spontaneous urticaria unresponsive to a standard dose and omalizumab as a second-line adjunct therapy for chronic spontaneous urticaria unresponsive to second-generation H1-antihistamines, patients are not always treated according to formal guideline recommendations. Usage of sedating first-generation H1-antihistamines, IV immunoglobulin, and long-term oral corticosteroids as primary treatments are common, and the high cost of the only approved biologic, XOLAIR, further dampens its use, despite all the benefits. Further, almost one-third of patients remain symptomatic despite using omalizumab, and the SC administration route further burdens the healthcare infrastructure and patients. H2-antagonists and dapsone though not recommended, still have relevance as they are affordable in some restricted healthcare systems.

The current Chronic Spontaneous Urticaria Pipeline, though, mostly has adjuncts to treat refractory cases, they are still novel molecules like BTK inhibitors, interleukins inhibitors, and siglec-8-directed agonists, targeting novel pathways in chronic spontaneous urticaria that have shown significant improvements in UAS7 scores with improved safety profiles in early-stage trials. There is hope that the entry of these biologics and drugs will provide options based on patient-specific needs. Further, the competition will end the monopoly and hopefully improve the accessibility of biologics, which ensures more patient compliance than OTC therapies. However, there is still a need for personalized curative monotherapies that cure the disease rather than relieve the symptoms.

Chronic Spontaneous Urticaria Drugs Market: Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy. To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.

Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Chronic Spontaneous Urticaria Therapeutics Market Access and Reimbursement

The guidelines recommend second-generation H1-antihistamine as a first-line treatment for all types of urticaria. X of second-generation H1- antihistamine up to fourfold in patients with CU unresponsive to a standard dose is recommended as a second-line treatment before other treatments are considered. The guidelines further recommend the only approved monoclonal antibody, omalizumab, for treating patients with CU unresponsive to high-dose antihistamines. Cyclosporine is used off-label and is recommended only for patients with severe disease, refractory to any dose of antihistamine and omalizumab in combination.

XOLAIR Copay Program is specific for patients who have commercial health insurance. Patients under Medicare, Medicaid, or any federal or state-level program are not eligible. The patient is enrolled in the copay program, which means that after reaching the maximum program benefit, the patient would bear all out-of-pocket costs. The patient must pay USD 5/XOLAIR out-of-pocket expenses, and the company will cover the remaining USD 10,000/12-month period. There is no income limit to avail of this program.

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Chronic Spontaneous Urticaria Therapeutics Market Report Scope

• The Chronic Spontaneous Urticaria therapeutics market report covers a segment of key events, an executive summary, and a descriptive overview of chronic spontaneous urticaria, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current Chronic Spontaneous Urticaria Treatment Market Landscape.
• A detailed review of the Chronic Spontaneous Urticaria Treatment Market, historical and forecasted Chronic Spontaneous Urticaria Market Size, Chronic Spontaneous Urticaria Drugs Market Share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM chronic spontaneous urticaria market.

Chronic Spontaneous Urticaria Therapeutics Market Report Insights

• Patient-based Chronic Spontaneous Urticaria Market Forecasting
• Therapeutic Approaches
• Chronic Spontaneous Urticaria Pipeline Drugs Analysis
• Chronic spontaneous urticaria Market Size and Trends
• Existing and Future Chronic Spontaneous Urticaria Drugs Market Opportunity

Chronic Spontaneous Urticaria Therapeutics Market Report Key Strengths

• 11 years Chronic Spontaneous Urticaria Market Forecast
• The 7MM Coverage
• Chronic spontaneous urticaria Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Chronic Spontaneous Urticaria Drugs Uptake
• Key Chronic Spontaneous Urticaria Market Forecast Assumptions

Chronic Spontaneous Urticaria Therapeutics Market Report Assessment

• Current Chronic Spontaneous Urticaria Treatment Market Practices
• Chronic Spontaneous Urticaria Unmet Needs
• Chronic Spontaneous Urticaria Pipeline Drugs Profiles
• Chronic Spontaneous Urticaria Drugs Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions:

Chronic Spontaneous Urticaria Treatment Market Insights

• What was the total Chronic Spontaneous Urticaria Treatment Market Size, the Chronic Spontaneous Urticaria Market Size by therapies, and market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
• How will remibrutinib (LOU064) affect the treatment paradigm of chronic spontaneous urticaria?
• How will XOLAIR (omalizumab) compete with similar-class products and off-label therapies?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and marketed therapies?
• How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Chronic Spontaneous Urticaria Epidemiology Insights

• What are the disease risks, burdens, and Chronic Spontaneous Urticaria Unmet Needs? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to chronic spontaneous urticaria?
• What is the historical and forecasted chronic spontaneous urticaria patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• Out of the countries mentioned above, which country would have the highest diagnosed prevalent chronic spontaneous urticaria population during the forecast period (2024-2034)?
• What factors are contributing to the growth of chronic spontaneous urticaria cases?

Current Chronic Spontaneous Urticaria Treatment Market Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of chronic spontaneous urticaria? What are the current clinical and treatment guidelines for treating chronic spontaneous urticaria?
• How many companies are developing therapies for the treatment of chronic spontaneous urticaria?
• How many emerging therapies are in the mid-stage and late stage of development for treating chronic spontaneous urticaria?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What is the cost burden of current treatment on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the accessibility issues of approved therapy in the US?
• What is the 7MM historical and forecasted Chronic Spontaneous Urticaria Drugs Market?

Reasons to Buy:

• The Chronic Spontaneous Urticaria therapeutics market report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the chronic spontaneous urticaria drugs market.
• Insights on patient burden/disease Chronic Spontaneous Urticaria Prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing Chronic Spontaneous Urticaria Drugs Market opportunities in varying geographies and the growth potential over the coming years.
• The distribution of historical and current patient share is based on real-world prescription data in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying upcoming solid players in the Chronic Spontaneous Urticaria Drugs Market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies for chronic spontaneous urticaria, barriers to accessibility of approved therapy, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing Chronic Spontaneous Urticaria Drugs Market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Chronic Spontaneous Urticaria Market Overview at a Glance

• 3.1. Market Share (%) Distribution of Chronic Spontaneous Urticaria in 2020
• 3.2. Market Share (%) Distribution of Chronic Spontaneous Urticaria in 2034

4. Methodology of Chronic Spontaneous Urticaria Epidemiology and Market

5. Executive Summary of Chronic Spontaneous Urticaria

6. Key Events

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Signs and Symptoms
• 7.3. Classification
  • 7.3.1. Classification of Urticaria Based on its Duration and the Relevance of Eliciting Factors
• 7.4. Causes
• 7.5. Etiology
• 7.6. Pathophysiology
  • 7.6.1. Role of Mast Cells
  • 7.6.2. Serum Factors
  • 7.6.3. Coagulation Cascade
  • 7.6.4. Basophils
  • 7.6.5. Eosinophils
  • 7.6.6. Lymphocytes
  • 7.6.7. Autoimmune Theory
• 7.7. Clinical Manifestation
• 7.8. Diagnosis
  • 7.8.1. Acute Urticaria Diagnosis
  • 7.8.2. Chronic Spontaneous Urticaria
  • 7.8.3. Auto-reactive Urticaria
  • 7.8.4. Wheals and Angioedema are not Always Urticaria
  • 7.8.5. Histologic Findings
• 7.9. Treatment and Management
  • 7.9.1. Nonsedating Antihistamines
  • 7.9.2. Leukotriene Receptor Antagonists
  • 7.9.3. Cyclosporine A
  • 7.9.4. Omalizumab
  • 7.9.5. Methotrexate
  • 7.9.6. Azathioprine and Mycophenolate Mofetil
  • 7.9.7. Dapsone
  • 7.9.8. Other Drugs
• 7.10. Treatment for Chronic Spontaneous Urticaria
  • 7.10.1. Treatment of Urticaria in Children
  • 7.10.2. Treatment of Urticaria During Pregnancy and Lactation
  • 7.10.3. Treatment of Angioedema
  • 7.10.4. EAACI/GA2LEN/EDF/WAO Guideline
  • 7.10.5. BSACI Guidelines for the Management of Chronic Urticaria and Angio-oedema
  • 7.10.6. Guidelines Supported by the Centre of Evidence of the French Society of Dermatology
  • 7.10.7. Treatment Algorithm
• 7.11. Management of Chronic Spontaneous Urticaria

8. Patient Journey

9. Epidemiology and Patient Population

• 9.1. Key Findings
• 9.2. Assumptions and Rationale: The 7MM
  • 9.2.1. Diagnosed Prevalent Cases of Chronic Urticaria
  • 9.2.2. Type-specific Cases of Chronic Urticaria
  • 9.2.3. Age-specific Cases of Chronic Spontaneous Urticaria
  • 9.2.4. Gender-specific Cases of Chronic Spontaneous Urticaria
  • 9.2.5. Severity-specific Cases of Chronic Spontaneous Urticaria
• 9.3. Total Diagnosed Prevalent Cases of Chronic Spontaneous Urticaria in the 7MM
• 9.4. The US
  • 9.4.1. Total Diagnosed Prevalent Cases of Chronic Urticaria in the US
  • 9.4.2. Type-specific Cases of Chronic Urticaria in the US
  • 9.4.3. Gender-specific Cases of Chronic Spontaneous Urticaria in the US
  • 9.4.4. Age-specific Cases of Chronic Spontaneous Urticaria in the US
  • 9.4.5. Severity-specific Cases of Chronic Spontaneous Urticaria in the US
• 9.5. EU4 and the UK
  • 9.5.1. Total Diagnosed Prevalent Cases of Chronic Urticaria in EU4 and the UK
  • 9.5.2. Type-specific Cases of Chronic Urticaria in the EU4 and the UK
  • 9.5.3. Gender-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK
  • 9.5.4. Age-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK
  • 9.5.5. Severity-specific Cases of Chronic Spontaneous Urticaria in EU4 and the UK
• 9.6. Japan
  • 9.6.1. Total Diagnosed Prevalent Cases of Chronic Urticaria in Japan
  • 9.6.2. Type-specific Cases of Chronic Urticaria in Japan
  • 9.6.3. Gender-specific Cases of Chronic Spontaneous Urticaria in Japan
  • 9.6.4. Age-specific Cases of Chronic Spontaneous Urticaria in Japan
  • 9.6.5. Severity-specific Cases of Chronic Spontaneous Urticaria in Japan

10. Marketed Drugs

• 10.1. XOLAIR (omalizumab): Roche/Novartis
  • 10.1.1. Product Description
  • 10.1.2. Regulatory Milestones
  • 10.1.3. Other Development Activities
  • 10.1.4. Clinical Development
  • 10.1.5. Clinical Trials Information
  • 10.1.6. Safety and Efficacy
  • 10.1.7. Product Profile

11. Emerging Drugs

• 11.1. Key Cross Competition
• 11.2. Remibrutinib (LOU064): Novartis Pharmaceuticals
  • 11.2.1. Drug Description
  • 11.2.2. Clinical Development
  • 11.2.3. Clinical Trials Information
  • 11.2.4. Safety and Efficacy
  • 11.2.5. Product Profile
  • 11.2.6. Analysts' Views
• 11.3. DUPIXENT (dupilumab): Sanofi/Regeneron
  • 11.3.1. Product Description
  • 11.3.2. Other Developmental Activity
  • 11.3.3. Clinical Development
  • 11.3.4. Clinical Trials Information
  • 11.3.5. Safety and Efficacy
  • 11.3.6. Product Profile
  • 11.3.7. Analysts' Views
• 11.4. FASENRA (benralizumab): AstraZeneca/Kyowa Hakko Kirin
  • 11.4.1. Product Description
  • 11.4.2. Other Developmental Activity
  • 11.4.3. Clinical Development
  • 11.4.4. Clinical Trials Information
  • 11.4.5. Safety and Efficacy
  • 11.4.6. Product Profile
  • 11.4.7. Analysts' Views
• 11.5. Lirentelimab (AK002): Allakos/BioWa
  • 11.5.1. Drug Description
  • 11.5.2. Other Developmental Activity
  • 11.5.3. Clinical Development
  • 11.5.4. Clinical Trials Information
  • 11.5.5. Safety and Efficacy
  • 11.5.6. Product Profile
  • 11.5.7. Analysts' Views
• 11.6. TEZSPIRE (tezepelumab): AstraZeneca/Amgen
  • 11.6.1. Product Description
  • 11.6.2. Other Developmental Activity
  • 11.6.3. Clinical Development
  • 11.6.4. Clinical Trials Information
  • 11.6.5. Product Profile
  • 11.6.6. Analysts' Views
• 11.7. Rilzabrutinib (SAR444671): Sanofi
  • 11.7.1. Product Description
  • 11.7.2. Other Developmental Activity
  • 11.7.3. Clinical Development
  • 11.7.4. Clinical Trials Information
  • 11.7.5. Product Profile
• 11.8. TAS5315: Taiho Pharmaceutical
  • 11.8.1. Drug Description
  • 11.8.2. Clinical Development
  • 11.8.3. Clinical Trials Information
  • 11.8.4. Product Profile
• 11.9. Barzolvolimab (CDX-0159): Celldex Therapeutics
  • 11.9.1. Product Description
  • 11.9.2. Other Developmental Activity
  • 11.9.3. Clinical Development
  • 11.9.4. Clinical Trials Information
  • 11.9.5. Safety and Efficacy
  • 11.9.6. Product Profile

12. Chronic Spontaneous Urticaria: Market Analysis

• 12.1. Key Findings
• 12.2. Key Market Forecast Assumptions
• 12.3. Market Outlook
• 12.4. Attribute Analysis
• 12.5. Total Market Size of Chronic Spontaneous Urticaria in the 7MM
• 12.6. Total Market Size of Chronic Spontaneous Urticaria by Therapies in the 7MM
• 12.7. Total Market Size of Chronic Spontaneous Urticaria in the US
  • 12.7.1. Total Market Size of Chronic Spontaneous Urticaria
  • 12.7.2. The Market Size of Chronic Spontaneous Urticaria by Therapies
• 12.8. Market Size of Chronic Spontaneous Urticaria in EU4 and the UK
  • 12.8.1. Total Market Size of Chronic Spontaneous Urticaria
  • 12.8.2. The Market Size of Chronic Spontaneous Urticaria by Therapies
• 12.9. Market Size of Chronic Spontaneous Urticaria in Japan
  • 12.9.1. Total Market Size of Chronic Spontaneous Urticaria
  • 12.9.2. The Market Size of Chronic Spontaneous Urticaria by Therapies

13. Key Opinion Leaders' Views

14. SWOT

15. Unmet needs

16. Market Access and Reimbursement

• 16.1. The United States
  • 16.1.1. Centre for Medicare & Medicaid Services (CMS)
• 16.2. In EU4 and the UK
  • 16.2.1. Germany
  • 16.2.2. France
  • 16.2.3. Italy
  • 16.2.4. Spain
  • 16.2.5. The United Kingdom
• 16.3. Japan
  • 16.3.1. MHLW

17. Appendix

• 17.1. Bibliography
• 17.2. Acronyms and Abbreviations
• 17.3. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer